Trials / Active Not Recruiting
Active Not RecruitingNCT05812027
A Screening Study to Collect Samples for TAA, HLA & HLA Loss of Heterozygosity in Patients With Metastatic Solid Tumors
Screening Study to Determine HLA Type, HLA Loss of Heterozygosity Status and Tumor Antigen Expression in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumors
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,150 (estimated)
- Sponsor
- TScan Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous T cells are engineered to express a T cell receptor that recognizes tumor-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules. The purpose of this screening study is to collect samples to conduct HLA genotyping, HLA Loss of Heterozygosity (LOH) assessment, and expression of Tumor-associated Antigens (TAA) testing. These results will be used to determine if participants meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical study.
Detailed description
This multicenter screening study will be conducted to determine a participant's tumor-associated antigen expression, HLA types and loss of HLA heterozygosity status for potential enrollment in a TScan sponsored clinical study. No treatment intervention will occur as part of this screening study. Participants will be required to provide a buccal swab to assess their HLA types and a saliva sample to assess for HLA loss of heterozygosity. For participants with an HLA type for which TScan has an open clinical study, archival tissue (less than 8 months old) will be needed to assess for tumor-associated antigen expression. If archival tissue is not available or older than 8 months, a fresh tumor biopsy will be required.
Conditions
- Head and Neck Cancer
- Cervical Cancer
- Non Small Cell Lung Cancer
- HPV16 Related Cancers
- Sarcoma
- Uveal Melanoma
- NUT Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Tumor and HLA Profiling | HLA genotyping and tumor tissue profiling for certain tumor-associated antigens and HLA LOH. |
Timeline
- Start date
- 2023-06-26
- Primary completion
- 2026-01-01
- Completion
- 2027-01-14
- First posted
- 2023-04-13
- Last updated
- 2025-11-17
Locations
21 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05812027. Inclusion in this directory is not an endorsement.